BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇷 Brazil

    Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200

    K Number: K223784 · Decision Apr 18, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    839
    Registration Numbers
    839
    Same Product Code
    2251
    Applicant Total
    1
    Review Days
    123

    Basic Information

    Device Name
    Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200
    K Number
    K223784
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Deltronix Equipamentos Ltda
    Date Received
    December 16, 2022
    Decision Date
    April 18, 2023
    Product Code
    GEI
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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